Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease (STICH)

• ClinicalTrials.gov Identifier: NCT00023595
• Recruitment Status: Completed
• First Posted: September 11, 2001
• Results First Posted: July 24, 2017
• Last Update Posted: September 19, 2019
• Sponsor: Duke University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

This study will compare medical therapy with coronary bypass surgery and/or surgical ventricular reconstruction for patients with congestive heart failure and coronary artery disease (CAD).

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases; Coronary Disease; Heart Failure, Congestive; Heart Diseases	Procedure: CABG surgery plus MED; Drug: Active Medication Alone; Procedure: CABG plus MED and SVR	Phase 3

Detailed Description:

BACKGROUND:

Congestive heart failure afflicts approximately five million Americans and is the leading cause of hospitalization in Americans over the age of 65. Most cases of congestive heart failure are due to CAD. Surprisingly little is known about the relative benefits of medical versus surgical therapy for patients with obstructive coronary disease and congestive heart failure. Randomized studies of medical therapy versus bypass surgery for obstructive coronary disease were conducted in the 1970s and did not include the systematic use of aspirin, arterial conduits, or lipid-lowering medications. In addition, patients with ejection fractions below 35% were specifically excluded from the three large randomized studies of medical therapy versus bypass surgery. While observational data from the 1970s and early 1980s suggest a survival advantage associated with bypass surgery in patients with low ejection fraction and congestive heart failure, biases favoring the referral of the fittest of such patients for bypass surgery may have confounded these comparisons. In addition, medical therapy for congestive heart failure has improved dramatically over the past two decades. Thus, the choice of medical therapy versus bypass surgery for patients with congestive heart failure and obstructive coronary disease is usually decided by guesswork. This study is designed to provide a solid answer.

PURPOSE:

STICH is a multicenter, international, randomized trial that addresses two specific primary hypotheses in patients with clinical heart failure (HF) and left ventricular (LV) dysfunction who have coronary artery disease amenable to surgical revascularization.

The first hypothesis is that restoration of blood flow by means of coronary revascularization recovers chronic LV dysfunction and improves survival, as compared to intensive medical therapy alone. The second hypothesis is that surgical ventricular restoration (SVR) to a more normal LV size improves survival free of subsequent hospitalization for cardiac cause compared to CABG alone.

Patients eligible for either medical therapy or CABG, but not eligible for the SVR procedure (Stratum A), will be randomized in equal proportions to medical therapy alone versus CABG plus medical therapy. Patients eligible for all three therapies (Stratum B) will be randomized in equal proportions to medical therapy alone, CABG plus medical therapy, and CABG plus SVR plus medical therapy. Patients whose severity of angina or CAD makes them inappropriate for medical therapy alone (Stratum C) will be randomized in equal proportions to CABG plus medical therapy versus CABG plus SVR plus medical therapy.

The overall target was to recruit 1200 patients into Hypothesis One and 1,000 patients into Hypothesis Two. Secondary endpoints include the role of myocardial viability, morbidity, economics, and quality of life. Core laboratories for quality of life/economics, cardiac magnetic resonance (CMR), echocardiography (ECHO), neurohormonal/cytokine/genetic (NCG), and radionuclide (RN) studies ensure consistent testing practices and standardization of data necessary to identify eligible patients and to address specific questions related to the stated hypotheses.

IMPORTANCE OF RESEARCH:

The most common cause of HF is no longer hypertension or valvular heart disease as it was in previous decades, but rather CAD. HF is a common worldwide disease and CAD is a frequent cause of HF initiation and progression. HF is responsible for approximately 1 million hospitalizations and 300,000 fatalities annually. The prevalence of HF is increasing, largely due to enhanced survival following acute myocardial infarction and other manifestations of CAD. No randomized trial has ever compared directly the long-term benefits of surgical, medical, or combined surgical and medical treatment of patients with ischemic HF. The STICH trial is the first trial to compare the long term benefits of surgical and medical treatment in patients with ischemic HF. Although modern medical therapy for HF modestly improves quality of life, a more aggressive approach with the surgical therapies being studied in the STICH trial may produce even greater improvements. The common clinical practice of not offering CABG to patients with LV dysfunction in regions found to be nonviable on noninvasive studies is not evidence-based. Since only those patients for whom intensive medical therapy is the only reasonable therapeutic alternative are excluded from this study, the results of the STICH trial should be applicable to most patients with CAD, HF, and systolic LV dysfunction. The results of the STICH trial will also establish whether measurements of neurohormonal and cytokine levels and genetic profiling are useful for directing patient management decisions, for monitoring the effectiveness of therapy, and for refining the optimal approach for selecting the treatment strategy most likely to be effective for the many of these patients.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Surgical Treatment for Ischemic Heart Failure (STICH)
• Study Start Date: January 2002
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: November 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: H01: Medication; Medical therapy alone to treat Coronary Artery Disease	Drug: Active Medication Alone; Standard medication for coronary artery disease and heart failure management.; Other Name: Standard medications for management of CAD and heart failure
Active Comparator: H01: Medication + CABG; Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease	Procedure: CABG surgery plus MED; CABG plus standard medication management for Coronary Artery Disease
Active Comparator: H02: Medication+CABG; Coronary artery bypass graft surgery (CABG) plus Medication to treat coronary artery disease	Procedure: CABG surgery plus MED; CABG plus standard medication management for Coronary Artery Disease
Active Comparator: H02: Medication+CABG+SVR; CABG plus Medication and Surgical ventricular reconstruction (SVR)	Procedure: CABG plus MED and SVR; H02: the experimental arm receives active medical therapy and CABG and surgical ventricular restoration whereas the control group receives active medical therapy and CABG; for H01: the experimental arm receives active medical therapy and CABG whereas the control group receives active medical therapy alone

Outcome Measures

Primary Outcome Measures :

1. H01: All Cause Mortality [ Time Frame: 5 years post randomization ]
2. H01: All Cause Mortality [ Time Frame: 10 years post randomization ]
3. H02: All-cause Mortality or Cardiovascular Hospitalization [ Time Frame: 5 years post randomization ]

Secondary Outcome Measures :

1. H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). [ Time Frame: 10 years post randomization ]
2. H01: Cardiovascular Mortality (Defined as Sudden Death or Death Attributed to Recurrent MI, HF, a Cardiovascular Procedure, Stroke, or Other Cardiovascular Etiology). [ Time Frame: 5 years post randomization ]
3. H01: Mortality or Cardiovascular Hospitalization [ Time Frame: up to 5 years post randomization ]
4. H01: Mortality or Cardiovascular Hospitalization [ Time Frame: up to 10 years post randomization ]
5. H02: All-cause Mortality [ Time Frame: up to 5 years ]
6. H01: All-cause Mortality Within 30 Days After Randomization [ Time Frame: 30 days post randomization ]
7. H02: All-cause Mortality Within 30 Days After Randomization [ Time Frame: 30 days post randomization ]
8. H01: All-cause Mortality or Heart-failure Hospitalization [ Time Frame: 5 years post randomization ]
9. H02: All-cause Mortality or Heart-failure Hospitalization [ Time Frame: 5 years post randomization ]
10. H01: All-cause Mortality or Heart-failure Hospitalization [ Time Frame: 10 years post randomization ]
11. H01: Heart Failure Hospitalization [ Time Frame: 5 years post randomization ]
12. H02: Heart Failure Hospitalization [ Time Frame: 5 years post randomization ]
13. H01: Heart Failure Hospitalization [ Time Frame: 10 years post randomization ]
14. H01: Cardiac Procedure: Heart Transplant [ Time Frame: 5 years post randomization ]
15. H02: Cardiac Procedure: Heart Transplant [ Time Frame: 5 years post randomization ]
16. H01: Cardiac Procedure: Heart Transplant [ Time Frame: 10 years post randomization ]
17. H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) [ Time Frame: 5 years post randomization ]
18. H02: Cardiac Procedure: Left Ventricular Assist Device (LVAD) [ Time Frame: 5 years post randomization ]
19. H01: Cardiac Procedure: Left Ventricular Assist Device (LVAD) [ Time Frame: 10 years post randomization ]
20. H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) [ Time Frame: 5 years post randomization ]
21. H02: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) [ Time Frame: 5 years post randomization ]
22. H01: Cardiac Procedure: Implantable Cardioverter Defibrillator (ICD) [ Time Frame: 10 years post randomization ]
23. H01: Stroke [ Time Frame: 5 years post randomization ]
24. H01: Stroke [ Time Frame: 10 years post randomization ]
25. H02: Stroke [ Time Frame: 5 years post randomization ]
26. H01: All-cause Mortality or Revascularization (CABG or PCI) [ Time Frame: 5 years post randomization ]
    CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
27. H02: All-cause Mortality or Revascularization (CABG or PCI) [ Time Frame: 5 years post randomization ]
    CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
28. H01: All-cause Mortality or Revascularization (CABG or PCI) [ Time Frame: 10 years post randomization ]
    CABG = coronary artery bypass grafting. For patients randomized to CABG or CABG +SVR group, this represents the repeat CABG received during follow-up. PCI = Percutaneous Coronary Intervention.
29. H01: All-cause Mortality, Heart Transplant or LVAD [ Time Frame: 5 years post randomization ]
    LVAD=Left Ventricular Assist Device
30. H02: All-cause Mortality, Heart Transplant or LVAD [ Time Frame: 5 years post randomization ]
31. H01: All-cause Mortality, Heart Transplant or LVAD [ Time Frame: 10 years post randomization ]
    LVAD=Left Ventricular Assist Device
32. H01: All-cause (Unplanned and Elective) Hospitalization [ Time Frame: 5 years post randomization ]
33. H02: All-cause (Unplanned and Elective) Hospitalization [ Time Frame: 5 years post randomization ]
34. H01: All-cause (Unplanned and Elective) Hospitalization [ Time Frame: 10 years post randomization ]
35. H01: 6 Minute Walk Distance [ Time Frame: From randomization to 24 month follow-up ]
36. H02: 6 Minute Walk Distance [ Time Frame: From randomization to 24 month follow-up ]
37. H01: Exercise Duration [ Time Frame: From randomization to 24 months follow-up ]
    Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
38. H02: Exercise Duration [ Time Frame: From randomization to 24 months follow-up ]
    Record the total duration of exercise in minutes and seconds for patients performing the modified Bruce exercise treadmill test
39. H01: LVEF by ECHO Core Lab During Follow-up [ Time Frame: From randomization to 24 months follow-up ]
    Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
40. H02: LVEF by ECHO Core Lab During Follow-up [ Time Frame: From randomization to 24 months follow-up ]
    Left ventricular ejection fraction (LVEF) measured by Echocardiography (ECHO) core lab
41. H01: LVEF by RN Core Lab During Follow-up [ Time Frame: From randomization to 24 months follow-up ]
    Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
42. H02: LVEF by RN Core Lab During Follow-up [ Time Frame: From randomization to 24 months follow-up ]
    Left ventricular ejection fraction (LVEF) measured by radionuclide (RN) core lab.
43. H01: LVEF by CMR Core Lab During Follow-up [ Time Frame: From randomization to 24 months follow-up ]
    Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
44. H02: LVEF by CMR Core Lab During Follow-up [ Time Frame: From randomization to 24 months follow-up ]
    Left ventricular ejection fraction (LVEF) measured by cardiovascular magnetic resonance (CMR) core lab.
45. H01: B-type Natriuretic Peptide (BNP) [ Time Frame: From randomization to 24 months follow-up ]
    B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
46. H02: B-type Natriuretic Peptide (BNP) [ Time Frame: From randomization to 24 months follow-up ]
    B-type natriuretic peptide (BNP) by Neurohormonal/cytokine/genetic (NCG) core lab during follow-up
47. H01: SF-36 Mental Health Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    Short Form 36 Health Status Questionnaire (SF-36) Mental Health Subscale: These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
48. H02: SF-36 Mental Health Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 5 items assess anxiety, depression, emotional control, and psychological well-being. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better mental health. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
49. H01:SF-36 Role Physical Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
50. H02: SF-36 Role Physical Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 4 items assess limitations and difficulty performing work or other usual activities as a result of one's physical health. Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
51. H01:SF-36 Role Emotional Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
52. H02: SF-36 Role Emotional Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 3 items assess limitations and difficulty performing work or other usual activities as a result of any emotional problems (such as feeling depressed or anxious). Response choices are either "Yes" (1) or "No" (2). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better outcomes. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
53. H01:SF-36 Social Functioning Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
54. H02: SF-36 Social Functioning Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 2 items assess the limitations on social activities with others. Response choices range from "Extremely" or "All of the time" (1) to "Not at all" or "None of the time" (5). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better social functioning. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
55. H01:SF-36 Vitality Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
56. H02: SF-36 Vitality Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 4 items assess energy level and fatigue. Response choices range from "All of the time" (1) to "None of the time" (6). Item values are summed and then transformed to a 0-100 scale where higher scores indicate better vitality. (Final scores are normalized to a mean of 50 and standard deviation of 10.)
57. H01:SF-12 Physical Component Summary (PCS) Scale [ Time Frame: From enrollment to 3-year follow-up ]
    Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.
58. H02: SF-12 Physical Component Summary (PCS) Scale [ Time Frame: From enrollment to 3-year follow-up ]
    Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "physical" regression weights from the general US population and summed to produce the PCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "physical" constant from the scoring table to the sum of the 35 products.
59. H01: SF-12 Mental Component Summary (MCS) Scale [ Time Frame: From enrollment to 3-year follow-up ]
    Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.
60. H02: SF-12 Mental Component Summary (MCS) Scale [ Time Frame: From enrollment to 3-year follow-up ]
    Twelve items that reflect both physical and mental health are selected from the SF-36 subscales and combined according to an algebraic formula using published weights and constants: (a) First, the items are coded so that a higher value indicates better health; (b) then indicator variables (1/0) are created for the item response choice categories; (c) next, the 35 indicator variables are weighted using "mental" regression weights from the general US population and summed to produce the MCS-12 score; and (d) finally, a normalized score (with a mean of 50 and standard deviation of 10) is obtained by adding the "mental" constant from the scoring table to the sum of the 35 products.
61. H01: KCCQ Physical Limitation Scale [ Time Frame: From enrollment to 3-year follow-up ]

    Kansas City Cardiomyopathy Questionnaire (KCCQ)Physical Limitation Scale: These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

    .

62. H02: KCCQ Physical Limitation Scale [ Time Frame: From enrollment to 3-year follow-up ]
    These 6 items assess ability to perform various activities of daily living. Response choices range from "Extremely limited" (1) to "Not at all limited" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
63. H01: KCCQ Symptom Stability [ Time Frame: From enrollment to 3-year follow-up ]

    This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome.

    .

64. H02: KCCQ Symptom Stability [ Time Frame: From enrollment to 3-year follow-up ]
    This item assesses changes in shortness of breath or fatigue over the past 2 weeks. Response choices range from "Much worse" (1) to "Much better" (5). Item score is transformed to a 0-100 scale with a high score representing a better outcome.
65. H01: KCCQ Symptom Frequency [ Time Frame: From enrollment to 3-year follow-up ]

    These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

    .

66. H02: KCCQ Symptom Frequency [ Time Frame: From enrollment to 3-year follow-up ]
    These 4 items assess how many times the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices vary, but they range from "Every morning" or "Every night" or "All of the time" (1) to "Never over the past 2 weeks" (either 5 or 7). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
67. H01: KCCQ Symptom Burden [ Time Frame: From enrollment to 3-year follow-up ]
    These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
68. H02: KCCQ Symptom Burden [ Time Frame: From enrollment to 3-year follow-up ]
    These 3 items assess how much the patient has been bothered by shortness of breath, fatigue, and ankle swelling over the past 2 weeks. Response choices range from "extremely bothersome" (1) to "Not at all bothersome" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
69. H01: KCCQ Total Symptoms [ Time Frame: From enrollment to 3-year follow-up ]

    This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

    .

70. H02: KCCQ Total Symptoms [ Time Frame: From enrollment to 3-year follow-up ]
    This score represents the mean of the Symptom Frequency and Symptom Burden scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
71. H01: KCCQ Quality-of-Life Scale [ Time Frame: From enrollment to 3-year follow-up ]

    These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

    .

72. H02: KCCQ Quality-of-Life Scale [ Time Frame: From enrollment to 3-year follow-up ]
    These 3 items assess the effect of heart failure on the patient's enjoyment of life. Response choices range from 1 (worst state) to 5 (best state). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
73. H01: KCCQ Social Limitation [ Time Frame: From enrollment to 3-year follow-up ]

    These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

    .

74. H02: KCCQ Social Limitation [ Time Frame: From enrollment to 3-year follow-up ]
    These 4 items assess how much heart failure has affected the patient's lifestyle. Response choices range from "Severely limited" (1) to "Did not limit at all" (5). Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
75. H01: KCCQ Clinical Summary Score [ Time Frame: From enrollment to 3-year follow-up ]

    This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

    .

76. H02: KCCQ Clinical Summary Score [ Time Frame: From enrollment to 3-year follow-up ]
    This score represents the mean of the Physical Limitation and Total Symptom scores. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
77. H01: KCCQ Overall Summary Score [ Time Frame: From enrollment to 3-year follow-up ]

    This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.

    .

78. H02: KCCQ Overall Summary Score [ Time Frame: From enrollment to 3-year follow-up ]
    This score represents the mean of these 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
79. H01: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale [ Time Frame: From enrollment to 3-year follow-up ]

    These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina.

    .

80. H02: Seattle Angina Questionnaire (SAQ) Anginal Frequency Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 2 items assess the frequency of chest pain over the last 4 weeks. Response choices range from "4 or more times a day" (1) to "None" (6). The mean response is transformed to a 0-100 scale where higher scores reflect less frequent angina.
81. H01: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale [ Time Frame: From enrollment to 3-year follow-up ]

    This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina.

    .

82. H02: Seattle Angina Questionnaire (SAQ) Anginal Stability Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    This item assesses the change in chest pain over the last 4 weeks. Response choices range from "Much more often" (1) to "None" (6). The mean response is transformed to a 0-100 scale where 50 represents no change and a higher score indicates less angina.
83. H01:Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale [ Time Frame: From enrollment to 3-year follow-up ]

    These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.

    .

84. H02: Seattle Angina Questionnaire (SAQ) Quality-of-Life Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 3 items measure the patient's general satisfaction with life. Response choices range from 1 (least enjoyment) to 5 (high satisfaction). The mean score is transformed to a 0-100 scale where higher scores reflect better outcomes.
85. H01: EQ-5D Visual Analog Scale [ Time Frame: From enrollment to 3-year follow-up ]

    Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D): This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.

    .

86. H02: EQ-5D Visual Analog Scale [ Time Frame: From enrollment to 3-year follow-up ]
    This 0-100 scale records the patient's self-rated health on a vertical scale where 0 = worst imaginable health and 100 = perfect health.
87. H01: EQ-5D Health Status Index Score [ Time Frame: From enrollment to 3-year follow-up ]

    This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. These scores were multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.

    .

88. H02: EQ-5D Health Status Index Score [ Time Frame: From enrollment to 3-year follow-up ]
    This 5-item scale describes a patient's health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Choices for each dimension are "No problems" (1), "Moderate problems" (2), or "Extreme problems" (3). A scoring algorithm with utility weights is then applied to these 5 items to generate index scores ranging from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. (These scores can be multiplied by 100 to produce a scale from -11 to 100 that more closely resembles the Visual Analog Scale.)
89. H01: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale [ Time Frame: From enrollment to 3-year follow-up ]

    These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high.

    .

90. H02: Percentage of Patients With a Score of >= 16 on the Center for Epidemiological Studies Depression (CES-D) Scale [ Time Frame: From enrollment to 3-year follow-up ]
    These 20 items assess depressive symptomatology, and responses choices range from "Rarely or none of the time" (0) to "Most or all of the time" (3). Scale scores can therefore range from 0 to 60, although scores greater than or equal to 16 are considered high.
91. H01: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale [ Time Frame: From enrollment to 3-year follow-up ]

    These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.

    .

92. H02: Cardiac Self-Efficacy (CSE) Maintain Functioning Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 5 items assess patients' ability to maintain their usual social, family, and physical activities. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
93. H01: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale [ Time Frame: From enrollment to 3-year follow-up ]

    These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.

    .

94. H02: Cardiac Self-Efficacy (CSE) Control Symptoms Subscale [ Time Frame: From enrollment to 3-year follow-up ]
    These 8 items assess patients' ability to control symptoms such as chest pain and breathlessness by taking their medications and adjusting their activity levels. Response choices range from "Not at all confident" (1) to "Completely confident" (5). The mean score is transformed to a 0-100 scale where higher scores reflect more confidence.
95. H01: General Health Rating Scale [ Time Frame: From enrollment to 3-year follow-up ]

    This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.

    .

96. H02: General Health Rating Scale [ Time Frame: From enrollment to 3-year follow-up ]
    This single item asks patients to describe their health status over the past month on a scale from 0 to 100, where 0 = death and 100 = excellent health.
97. H01: Cost of Care [ Time Frame: index hospital admission ]
    Hospital costs and physician fees for US patients
98. H02: Cost of Care [ Time Frame: index hospital admission ]
    Hospital costs and physician fees for US patients

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• LV less than 35%, as defined by echocardiogram, left ventriculogram, CMR, or gated single photon emission computed tomography (SPECT) studies
• Coronary anatomy suitable for revascularization

Exclusion Criteria:

• Failure to provide informed consent.
• Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement.
• Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support.
• Plan for percutaneous intervention of CAD.
• Recent acute MI judged to be an important cause of left ventricular dysfunction.
• History of more than 1 prior coronary bypass operation.
• Noncardiac illness with a life expectancy of less than 3 years.
• Noncardiac illness imposing substantial operative mortality.
• Conditions/circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
• Previous heart, kidney, liver, or lung transplantation.
• Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.

MED Therapy Eligibility Criteria

• Absence of left main CAD as defined by an intraluminal stenosis of 50% or greater.
• Absence of CCS III angina or greater (angina markedly limiting ordinary activity).

SVR Eligibility Criterion

• Dominant akinesia or dyskinesia of the anterior left ventricular wall amenable to SVR.

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27715

Sponsors and Collaborators

Duke University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Robert Bonow; Radionuclide Core Lab, Northwestern University
• Principal Investigator: Arthur Feldman; Neurohormonal Core Lab, Jefferson University
• Principal Investigator: Eric Velazquez, MD; Clinical Coordinating Center, Duke University
• Principal Investigator: Kerry Lee; Data Coordinating Center, Duke University
• Principal Investigator: Daniel Mark; Economics and Quality of Life Core Lab, Duke University
• Principal Investigator: Jae Oh; Echocardiographic Core Lab, Mayo Clinic
• Principal Investigator: Gerald Pohost; Magnetic Resonance Imaging Core Lab, University of Southern California
• Study Chair: Jean Rouleau; Université de Montréal
• Principal Investigator: Julio A Panza, MD; Medstar Health Research Institute

More Information

Publications:

Velazquez EJ, Lee KL, O'Connor CM, Oh JK, Bonow RO, Pohost GM, Feldman AM, Mark DB, Panza JA, Sopko G, Rouleau JL, Jones RH; STICH Investigators. The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. J Thorac Cardiovasc Surg. 2007 Dec;134(6):1540-7. doi: 10.1016/j.jtcvs.2007.05.069.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chew DS, Cowper PA, Al-Khalidi H, Anstrom KJ, Daniels MR, Davidson-Ray L, Li Y, Michler RE, Panza JA, Pina IL, Rouleau JL, Velazquez EJ, Mark DB; STICH Investigators. Cost-Effectiveness of Coronary Artery Bypass Surgery Versus Medicine in Ischemic Cardiomyopathy: The STICH Randomized Clinical Trial. Circulation. 2022 Mar 15;145(11):819-828. doi: 10.1161/CIRCULATIONAHA.121.056276. Epub 2022 Jan 19.

Farsky PS, White J, Al-Khalidi HR, Sueta CA, Rouleau JL, Panza JA, Velazquez EJ, O'Connor CM; Working Group and Surgical Treatment for Ischemic Heart Failure Trial Investigators. Optimal medical therapy with or without surgical revascularization and long-term outcomes in ischemic cardiomyopathy. J Thorac Cardiovasc Surg. 2022 Dec;164(6):1890-1899.e4. doi: 10.1016/j.jtcvs.2020.12.094. Epub 2021 Jan 7.

Perry AS, Mann DL, Brown DL. Improvement of ejection fraction and mortality in ischaemic heart failure. Heart. 2020 Aug 25:heartjnl-2020-316975. doi: 10.1136/heartjnl-2020-316975. Online ahead of print.

Howlett JG, Stebbins A, Petrie MC, Jhund PS, Castelvecchio S, Cherniavsky A, Sueta CA, Roy A, Pina IL, Wurm R, Drazner MH, Andersson B, Batlle C, Senni M, Chrzanowski L, Merkely B, Carson P, Desvigne-Nickens PM, Lee KL, Velazquez EJ, Al-Khalidi HR; STICH Trial Investigators. CABG Improves Outcomes in Patients With Ischemic Cardiomyopathy: 10-Year Follow-Up of the STICH Trial. JACC Heart Fail. 2019 Oct;7(10):878-887. doi: 10.1016/j.jchf.2019.04.018. Epub 2019 Sep 11.

Panza JA, Ellis AM, Al-Khalidi HR, Holly TA, Berman DS, Oh JK, Pohost GM, Sopko G, Chrzanowski L, Mark DB, Kukulski T, Favaloro LE, Maurer G, Farsky PS, Tan RS, Asch FM, Velazquez EJ, Rouleau JL, Lee KL, Bonow RO. Myocardial Viability and Long-Term Outcomes in Ischemic Cardiomyopathy. N Engl J Med. 2019 Aug 22;381(8):739-748. doi: 10.1056/NEJMoa1807365.

Nicolau JC, Stevens SR, Al-Khalidi HR, Jatene FB, Furtado RHM, Dallan LAO, Lisboa LAF, Desvigne-Nickens P, Haddad H, Jolicoeur EM, Petrie MC, Doenst T, Michler RE, Ohman EM, Maddury J, Ali I, Deja MA, Rouleau JL, Velazquez EJ, Hill JA. Does prior coronary angioplasty affect outcomes of surgical coronary revascularization? Insights from the STICH trial. Int J Cardiol. 2019 Sep 15;291:36-41. doi: 10.1016/j.ijcard.2019.03.029. Epub 2019 Mar 15.

Ambrosy AP, Stevens SR, Al-Khalidi HR, Rouleau JL, Bouabdallaoui N, Carson PE, Adlbrecht C, Cleland JGF, Dabrowski R, Golba KS, Pina IL, Sueta CA, Roy A, Sopko G, Bonow RO, Velazquez EJ; STICH Trial Investigators. Burden of medical co-morbidities and benefit from surgical revascularization in patients with ischaemic cardiomyopathy. Eur J Heart Fail. 2019 Mar;21(3):373-381. doi: 10.1002/ejhf.1404. Epub 2019 Jan 30.

Pellikka PA, She L, Holly TA, Lin G, Varadarajan P, Pai RG, Bonow RO, Pohost GM, Panza JA, Berman DS, Prior DL, Asch FM, Borges-Neto S, Grayburn P, Al-Khalidi HR, Miszalski-Jamka K, Desvigne-Nickens P, Lee KL, Velazquez EJ, Oh JK. Variability in Ejection Fraction Measured By Echocardiography, Gated Single-Photon Emission Computed Tomography, and Cardiac Magnetic Resonance in Patients With Coronary Artery Disease and Left Ventricular Dysfunction. JAMA Netw Open. 2018 Aug 3;1(4):e181456. doi: 10.1001/jamanetworkopen.2018.1456.

Bouabdallaoui N, Stevens SR, Doenst T, Petrie MC, Al-Attar N, Ali IS, Ambrosy AP, Barton AK, Cartier R, Cherniavsky A, Demondion P, Desvigne-Nickens P, Favaloro RR, Gradinac S, Heinisch P, Jain A, Jasinski M, Jouan J, Kalil RAK, Menicanti L, Michler RE, Rao V, Smith PK, Zembala M, Velazquez EJ, Al-Khalidi HR, Rouleau JL; STICH Trial Investigators. Society of Thoracic Surgeons Risk Score and EuroSCORE-2 Appropriately Assess 30-Day Postoperative Mortality in the STICH Trial and a Contemporary Cohort of Patients With Left Ventricular Dysfunction Undergoing Surgical Revascularization. Circ Heart Fail. 2018 Nov;11(11):e005531. doi: 10.1161/CIRCHEARTFAILURE.118.005531.

Andersson B, She L, Tan RS, Jeemon P, Mokrzycki K, Siepe M, Romanov A, Favaloro LE, Djokovic LT, Raju PK, Betlejewski P, Racine N, Ostrzycki A, Nawarawong W, Das S, Rouleau JL, Sopko G, Lee KL, Velazquez EJ, Panza JA. The association between blood pressure and long-term outcomes of patients with ischaemic cardiomyopathy with and without surgical revascularization: an analysis of the STICH trial. Eur Heart J. 2018 Oct 1;39(37):3464-3471. doi: 10.1093/eurheartj/ehy438.

Stewart RAH, Szalewska D, Stebbins A, Al-Khalidi HR, Cleland JGH, Rynkiewicz A, Drazner MH, White HD, Mark DB, Roy A, Kosevic D, Rajda M, Jasinski M, Leng CY, Tungsubutra W, Desvigne-Nickens P, Velazquez EJ, Petrie MC. Six-minute walk distance after coronary artery bypass grafting compared with medical therapy in ischaemic cardiomyopathy. Open Heart. 2018 Feb 20;5(1):e000752. doi: 10.1136/openhrt-2017-000752. eCollection 2018.

Pina IL, Zheng Q, She L, Szwed H, Lang IM, Farsky PS, Castelvecchio S, Biernat J, Paraforos A, Kosevic D, Favaloro LE, Nicolau JC, Varadarajan P, Velazquez EJ, Pai RG, Cyrille N, Lee KL, Desvigne-Nickens P; STICH Trial Investigators. Sex Difference in Patients With Ischemic Heart Failure Undergoing Surgical Revascularization: Results From the STICH Trial (Surgical Treatment for Ischemic Heart Failure). Circulation. 2018 Feb 20;137(8):771-780. doi: 10.1161/CIRCULATIONAHA.117.030526.

Prior DL, Stevens SR, Holly TA, Krejca M, Paraforos A, Pohost GM, Byrd K, Kukulski T, Jones RH, Desvigne-Nickens P, Varadarajan P, Amanullah A, Lin G, Al-Khalidi HR, Aldea G, Santambrogio C, Bochenek A, Berman DS; STICH Trial Investigators. Regional left ventricular function does not predict survival in ischaemic cardiomyopathy after cardiac surgery. Heart. 2017 Sep;103(17):1359-1367. doi: 10.1136/heartjnl-2016-310693. Epub 2017 Apr 26.

Petrie MC, Jhund PS, She L, Adlbrecht C, Doenst T, Panza JA, Hill JA, Lee KL, Rouleau JL, Prior DL, Ali IS, Maddury J, Golba KS, White HD, Carson P, Chrzanowski L, Romanov A, Miller AB, Velazquez EJ; STICH Trial Investigators. Ten-Year Outcomes After Coronary Artery Bypass Grafting According to Age in Patients With Heart Failure and Left Ventricular Systolic Dysfunction: An Analysis of the Extended Follow-Up of the STICH Trial (Surgical Treatment for Ischemic Heart Failure). Circulation. 2016 Nov 1;134(18):1314-1324. doi: 10.1161/CIRCULATIONAHA.116.024800. Epub 2016 Aug 29.

Velazquez EJ, Lee KL, Jones RH, Al-Khalidi HR, Hill JA, Panza JA, Michler RE, Bonow RO, Doenst T, Petrie MC, Oh JK, She L, Moore VL, Desvigne-Nickens P, Sopko G, Rouleau JL; STICHES Investigators. Coronary-Artery Bypass Surgery in Patients with Ischemic Cardiomyopathy. N Engl J Med. 2016 Apr 21;374(16):1511-20. doi: 10.1056/NEJMoa1602001. Epub 2016 Apr 3.

Jolicoeur EM, Dunning A, Castelvecchio S, Dabrowski R, Waclawiw MA, Petrie MC, Stewart R, Jhund PS, Desvigne-Nickens P, Panza JA, Bonow RO, Sun B, San TR, Al-Khalidi HR, Rouleau JL, Velazquez EJ, Cleland JGF. Importance of angina in patients with coronary disease, heart failure, and left ventricular systolic dysfunction: insights from STICH. J Am Coll Cardiol. 2015 Nov 10;66(19):2092-2100. doi: 10.1016/j.jacc.2015.08.882.

Bonow RO, Castelvecchio S, Panza JA, Berman DS, Velazquez EJ, Michler RE, She L, Holly TA, Desvigne-Nickens P, Kosevic D, Rajda M, Chrzanowski L, Deja M, Lee KL, White H, Oh JK, Doenst T, Hill JA, Rouleau JL, Menicanti L; STICH Trial Investigators. Severity of Remodeling, Myocardial Viability, and Survival in Ischemic LV Dysfunction After Surgical Revascularization. JACC Cardiovasc Imaging. 2015 Oct;8(10):1121-1129. doi: 10.1016/j.jcmg.2015.03.013. Epub 2015 Sep 9.

Wrobel K, Stevens SR, Jones RH, Selzman CH, Lamy A, Beaver TM, Djokovic LT, Wang N, Velazquez EJ, Sopko G, Kron IL, DiMaio JM, Michler RE, Lee KL, Yii M, Leng CY, Zembala M, Rouleau JL, Daly RC, Al-Khalidi HR. Influence of Baseline Characteristics, Operative Conduct, and Postoperative Course on 30-Day Outcomes of Coronary Artery Bypass Grafting Among Patients With Left Ventricular Dysfunction: Results From the Surgical Treatment for Ischemic Heart Failure (STICH) Trial. Circulation. 2015 Aug 25;132(8):720-30. doi: 10.1161/CIRCULATIONAHA.114.014932.

MacDonald MR, She L, Doenst T, Binkley PF, Rouleau JL, Tan RS, Lee KL, Miller AB, Sopko G, Szalewska D, Waclawiw MA, Dabrowski R, Castelvecchio S, Adlbrecht C, Michler RE, Oh JK, Velazquez EJ, Petrie MC. Clinical characteristics and outcomes of patients with and without diabetes in the Surgical Treatment for Ischemic Heart Failure (STICH) trial. Eur J Heart Fail. 2015 Jul;17(7):725-34. doi: 10.1002/ejhf.288. Epub 2015 May 26.

Mark DB, Knight JD, Velazquez EJ, Wasilewski J, Howlett JG, Smith PK, Spertus JA, Rajda M, Yadav R, Hamman BL, Malinowski M, Naik A, Rankin G, Harding TM, Drew LA, Desvigne-Nickens P, Anstrom KJ. Quality-of-life outcomes with coronary artery bypass graft surgery in ischemic left ventricular dysfunction: a randomized trial. Ann Intern Med. 2014 Sep 16;161(6):392-9. doi: 10.7326/M13-1380.

Panza JA, Velazquez EJ, She L, Smith PK, Nicolau JC, Favaloro RR, Gradinac S, Chrzanowski L, Prabhakaran D, Howlett JG, Jasinski M, Hill JA, Szwed H, Larbalestier R, Desvigne-Nickens P, Jones RH, Lee KL, Rouleau JL. Extent of coronary and myocardial disease and benefit from surgical revascularization in ischemic LV dysfunction [Corrected]. J Am Coll Cardiol. 2014 Aug 12;64(6):553-61. doi: 10.1016/j.jacc.2014.04.064. Erratum In: J Am Coll Cardiol. 2014 Oct 7;64(14):1539.

Stewart RA, Szalewska D, She L, Lee KL, Drazner MH, Lubiszewska B, Kosevic D, Ruengsakulrach P, Nicolau JC, Coutu B, Choudhary SK, Mark DB, Cleland JG, Pina IL, Velazquez EJ, Rynkiewicz A, White H. Exercise capacity and mortality in patients with ischemic left ventricular dysfunction randomized to coronary artery bypass graft surgery or medical therapy: an analysis from the STICH trial (Surgical Treatment for Ischemic Heart Failure). JACC Heart Fail. 2014 Aug;2(4):335-43. doi: 10.1016/j.jchf.2014.02.009. Epub 2014 Jul 9.

Doenst T, Cleland JG, Rouleau JL, She L, Wos S, Ohman EM, Krzeminska-Pakula M, Airan B, Jones RH, Siepe M, Sopko G, Velazquez EJ, Racine N, Gullestad L, Filgueira JL, Lee KL; STICH Investigators. Influence of crossover on mortality in a randomized study of revascularization in patients with systolic heart failure and coronary artery disease. Circ Heart Fail. 2013 May;6(3):443-50. doi: 10.1161/CIRCHEARTFAILURE.112.000130. Epub 2013 Mar 20.

Panza JA, Holly TA, Asch FM, She L, Pellikka PA, Velazquez EJ, Lee KL, Borges-Neto S, Farsky PS, Jones RH, Berman DS, Bonow RO. Inducible myocardial ischemia and outcomes in patients with coronary artery disease and left ventricular dysfunction. J Am Coll Cardiol. 2013 May 7;61(18):1860-70. doi: 10.1016/j.jacc.2013.02.014. Epub 2013 Mar 7.

Oh JK, Velazquez EJ, Menicanti L, Pohost GM, Bonow RO, Lin G, Hellkamp AS, Ferrazzi P, Wos S, Rao V, Berman D, Bochenek A, Cherniavsky A, Rogowski J, Rouleau JL, Lee KL; STICH Investigators. Influence of baseline left ventricular function on the clinical outcome of surgical ventricular reconstruction in patients with ischaemic cardiomyopathy. Eur Heart J. 2013 Jan;34(1):39-47. doi: 10.1093/eurheartj/ehs021. Epub 2012 May 14.

Deja MA, Grayburn PA, Sun B, Rao V, She L, Krejca M, Jain AR, Leng Chua Y, Daly R, Senni M, Mokrzycki K, Menicanti L, Oh JK, Michler R, Wrobel K, Lamy A, Velazquez EJ, Lee KL, Jones RH. Influence of mitral regurgitation repair on survival in the surgical treatment for ischemic heart failure trial. Circulation. 2012 May 29;125(21):2639-48. doi: 10.1161/CIRCULATIONAHA.111.072256. Epub 2012 May 2.

Bonow RO, Maurer G, Lee KL, Holly TA, Binkley PF, Desvigne-Nickens P, Drozdz J, Farsky PS, Feldman AM, Doenst T, Michler RE, Berman DS, Nicolau JC, Pellikka PA, Wrobel K, Alotti N, Asch FM, Favaloro LE, She L, Velazquez EJ, Jones RH, Panza JA; STICH Trial Investigators. Myocardial viability and survival in ischemic left ventricular dysfunction. N Engl J Med. 2011 Apr 28;364(17):1617-25. doi: 10.1056/NEJMoa1100358. Epub 2011 Apr 4.

Velazquez EJ, Lee KL, Deja MA, Jain A, Sopko G, Marchenko A, Ali IS, Pohost G, Gradinac S, Abraham WT, Yii M, Prabhakaran D, Szwed H, Ferrazzi P, Petrie MC, O'Connor CM, Panchavinnin P, She L, Bonow RO, Rankin GR, Jones RH, Rouleau JL; STICH Investigators. Coronary-artery bypass surgery in patients with left ventricular dysfunction. N Engl J Med. 2011 Apr 28;364(17):1607-16. doi: 10.1056/NEJMoa1100356. Epub 2011 Apr 4.

Zembala M, Michler RE, Rynkiewicz A, Huynh T, She L, Lubiszewska B, Hill JA, Jandova R, Dagenais F, Peterson ED, Jones RH. Clinical characteristics of patients undergoing surgical ventricular reconstruction by choice and by randomization. J Am Coll Cardiol. 2010 Aug 3;56(6):499-507. doi: 10.1016/j.jacc.2010.03.054.

Jones RH, White H, Velazquez EJ, Shaw LK, Pietrobon R, Panza JA, Bonow RO, Sopko G, O'Connor CM, Rouleau JL. STICH (Surgical Treatment for Ischemic Heart Failure) trial enrollment. J Am Coll Cardiol. 2010 Aug 3;56(6):490-8. doi: 10.1016/j.jacc.2009.11.102.

Mark DB, Knight JD, Velazquez EJ, Howlett JG, Spertus JA, Djokovic LT, Harding TM, Rankin GR, Drew LA, Szygula-Jurkiewicz B, Adlbrecht C, Anstrom KJ; Surgical Treatment for Ischemic Heart Failure (STICH) Trial Investigators. Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial. Am Heart J. 2009 May;157(5):837-44, 844.e1-3. doi: 10.1016/j.ahj.2009.03.008. Epub 2009 Apr 1.

Jones RH, Velazquez EJ, Michler RE, Sopko G, Oh JK, O'Connor CM, Hill JA, Menicanti L, Sadowski Z, Desvigne-Nickens P, Rouleau JL, Lee KL; STICH Hypothesis 2 Investigators. Coronary bypass surgery with or without surgical ventricular reconstruction. N Engl J Med. 2009 Apr 23;360(17):1705-17. doi: 10.1056/NEJMoa0900559. Epub 2009 Mar 29.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00023595
• Other Study ID Numbers: Pro00018940; U01HL069009 ( U.S. NIH Grant/Contract ); U01HL069010 ( U.S. NIH Grant/Contract ); U01HL069011 ( U.S. NIH Grant/Contract ); U01HL069012 ( U.S. NIH Grant/Contract ); U01HL069013 ( U.S. NIH Grant/Contract ); U01HL069015 ( U.S. NIH Grant/Contract ); U01HL072683 ( U.S. NIH Grant/Contract ); R01HL105853 ( U.S. NIH Grant/Contract ); Pro00010463 ( Other Identifier: Duke IRB )
• First Posted: September 11, 2001
• Results First Posted: July 24, 2017
• Last Update Posted: September 19, 2019
• Last Verified: September 2019

Additional relevant MeSH terms:

Heart Failure; Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Vascular Diseases